This study is designed to evaluate the effects of glucocorticoid(GC) on improving post-operative organ dysfunction in patients with acute type A aortic dissection(aTAAD). Subjects with confirmed diagnosis of aTAAD undergoing surgical treatment will be enrolled and 1:1 randomly assigned to receive either glucocorticoids or normal treatment. All patients in the glucocorticoids group will be given methylprednisolone intravenously for 3 days after enrollment. The primary endpoint will be the amplitude of variation of Sequential Organ Failure Assessment score on post-operative day 4 compared to baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
212
All eligible patients randomised to the glucocorticoid group will receive intravenous Methylprednisolone for 3 days after surgery. The dosage is 2mg/kg/d on post-operative day 1, 1mg/kg/d on post-operative day 2, and 0.5mg/kg/d on post-operative day 3. The daily dosage will be administered with two injections (12h interval).
Zhongshan Hospital
Shanghai, Shanghai Municipality, China
Amplitude of variation of SOFA score on post-operative day 4 compared to baseline
Time frame: Within 4 days on admission to CSICU
In-hospital mortality
Time frame: Up to 30 days
Duration of ICU stay
Time frame: Up to 30 days
Duration of mechanical ventilation
Time frame: Up to 30 days
Duration of hospital stay
Time frame: Up to 30 days
The proportion of patients receiving RRT
Use of Renal Replacement Therapy(RRT)
Time frame: Up to 30 days
The duration of RRT will be compared between two groups.
Use of Renal Replacement Therapy(RRT)
Time frame: Up to 30 days
Incidence of Tracheostomy
Time frame: Up to 30 days
Incidence of Post-operative infection
Time frame: Up to 30 days
Changes in Inflammation markers
Inflammation markers include IL-1, IL2R, IL-6 and TNFa
Time frame: Within 3 days on admission to CSICU
Rate of Composite outcome
In-hospital mortality or Duration of ICU stay longer than 30 days or The need for tracheostomy
Time frame: Up to 30 days
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